System to permit offpump beating heart coronary bypass surgery

ABSTRACT

A system for manipulating and supporting a beating heart during cardiac surgery, including a gross support element for engaging and supporting the heart (the gross support element preferably including a head which is sized and shaped to cradle the myocardium of the left ventricle), a suspension head configured to exert lifting force on the heart when positioned near the apical region of the heart at a position at least partially overlying the right ventricle, and a releasable attachment element for releasably attaching at least one of the gross support element and the suspension head to the heart. The releasable attachment element can be a mechanical element (such as one or more staples or sutures) or an adhesive such as glue. Alternatively, the system includes a suspension head and a releasable attachment element for releasably attaching it to the heart, but does not include a gross support element.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part application of U.S.patent application Ser. No. 09/087,511 filed on May 29, 1998 (issued asU.S. Pat. No. 6,338,712), which is a continuation-in-part of U.S. patentapplication Ser. No. 08/936,184 filed on Sep. 17, 1997 (issued as U.S.Pat. No. 6,019,722) by the inventors of the present application.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to the general art of cardiac surgery, andto the particular field of heart retractors used in beating heartsurgery.

BACKGROUND OF THE INVENTION

There are as many as 300,000 coronary bypass graft procedures performedannually in the United States. Each of those procedures may include oneor more graft vessels. Currently, each graft vessel must be handsutured. As many as four or more grafts are placed in a procedure. Untilrecently, coronary artery bypass procedures have been performed with thepatient on cardiopulmonary bypass whereby the heart is stopped withcardioplegia and the surgery performed on an exposed and still heart.

The previous applications disclosed means and methods for manipulatingthe heart during cardiac surgery whereby the heart can be located andoriented into the most advantageous position and orientation for beatingheart surgery. Reference to those applications is made for a morecomplete discussion of the means and methods described.

Most particularly, the means and method described in those applicationsinclude using a gross support to support the heart and a means forengaging a selected section of the heart to immobilize that selectedsection as a surgery target while permitting non-engaged sections of theheart to move in a manner whereby essentially unabated cardiac output ismaintained while the heart is regionally immobilized.

The gross support means disclosed in the application filed on May 29,1998 includes a flexible cup that can move in a plurality of planes andwhich has a flexible rim for engaging the heart. The cup is releasablyattached to the heart. One means for releasably attaching the cup to theheart includes suction applied by the cup to the heart. Suction is thebest mode disclosed in the just-mentioned patent application.

As suction is readily available in most operating rooms, this is aneffective means for releasably attaching the elements to the heart.However, this means can be improved.

Therefore, there is a need for a means and method for improving thereleasable attachment between the elements of the heart manipulationsystem disclosed in the referenced patent applications and the heart.

The suction system disclosed in the referenced patent applications canalso benefit by being backed up whereby the heart will remain in thedesired position and orientation even if vacuum is lost or degraded.

Therefore, there is a need to provide a means for backing up the vacuumsystem used in the referenced patent applications to releasably attachthe elements of the system to the heart.

Operation of the heart was discussed in the referenced patentapplications and reference is made thereto for such disclosure so itwill not be repeated here.

Recently, there has been interest in minimally invasive coronary bypasssurgery. This is not surprising since a median sternotomy and a run onthe cardiopulmonary bypass pump are not well tolerated by some patients,combined with the added cost of coronary bypass equipment and staff. Theprocedure results in considerable recovery time and is associated with arisk of death and major complication. While the ultimate goal is toprovide bypass to all vessels by port access (like gallbladder surgery)and to eliminate the need for cardiopulmonary bypass, a more limited butreasonable option for the next number or years will be to perform bypassoff pump with an incision (sternotomy or thoracotomy). A tool whichcould allow performance of multivessel off pump bypass would be mosthelpful.

Therefore, the referenced patent applications disclosed a heartretractor which will support the heart in position for minimallyinvasive coronary bypass surgery of coronary arteries, including thecircumflex coronary artery, in a manner that will not damage the heartyet will provide easy access to the surgical target without requiringthe heart to be stopped yet without unduly constraining the heart.

These means and methods can also be improved by having additional meansand methods for releasably attaching the elements of the systems to theheart during minimally invasive surgery.

OBJECTS OF THE INVENTION

It is main object of the present invention to improve the performance ofthe system for manipulating a heart during cardiac surgery which wasdisclosed in the referenced patent applications.

It is another object of the present invention to improve the performanceof the retractors disclosed in the parent disclosures.

It is another object of the present invention to improve the performanceof the retractors disclosed in the parent disclosures by providingadditional means for releasably attaching the elements of those systemsto the heart.

It is a more specific object of the present invention to providemechanical means for releasably attaching elements of a system formanipulating a heart during cardiac surgery.

It is a more specific object of the present invention to provideadhesive means for releasably attaching elements of a system formanipulating a heart during cardiac surgery.

SUMMARY OF THE INVENTION

These, and other, objects are achieved by providing mechanical and/oradhesive means for releasably attaching the elements of a system formanipulating a heart during cardiac surgery.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 illustrates a suspension head mechanism such as disclosed inparent application Ser. No. 09/087,511 (now U.S. Pat. No. 6,338,712) forlifting the heart.

FIG. 2 illustrates one mechanical means for releasably attaching thesuspension head to the heart as including a suture.

FIG. 3 illustrates one mechanical means for releasably attaching thesuspension head to the heart as including a staple.

FIG. 4 is another view of the staple shown in FIG. 3 in the formedcondition.

FIG. 5 illustrates a staple-removing element.

FIG. 6 illustrates one mechanical means for releasably attaching thesuspension head to the heart as including a suture.

FIG. 7 is another form of the suture mechanical attaching means shown inFIG. 6.

FIG. 8 illustrates an adhesive means for attaching an element of theheart manipulation system to the heart.

FIG. 9 is a side, cross-sectional view of a portion of a heartmanipulation system disclosed in parent application Ser. No. 08/936,184(now U.S. Pat. No. 6,019,722).

FIG. 10 is a perspective view of a portion of a heart manipulationsystem of FIG. 9, with a stabilizing element of a type disclosed inparent application Ser. No. 08/936,184 (now U.S. Pat. No. 6,019,722).

FIG. 11 is a cross-sectional view of a multipart suction cup disclosedin parent application Ser. No. 09/087,511 (now U.S. Pat. No. 6,338,712).

FIG. 12 is a perspective view of a system, disclosed in parentapplication Ser. No. 09/087,511 (now U.S. Pat. No. 6,338,712), formanipulating a beating heart.

FIG. 13 is a perspective view of the system of FIG. 12, with surgerytarget immobilizing means, during cardiac surgery on a heart.

FIG. 14 is a perspective view of surgery target immobilizing means 340of FIG. 13.

FIG. 15 is an exploded perspective view of a portion of gross supportmeans 402 of the system of FIG. 12.

FIG. 16 is another exploded view of gross support means 402 of thesystem of FIG. 12.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION

The operation of a heart was discussed in the parent applications, andreference thereto is made for such discussion. Furthermore, thediscussion of various elements of a heart manipulation system were alsofully discussed in the parent applications.

FIGS. 9 and 10 correspond to FIGS. 3 and 5 of parent application Ser.No. 08/936,184 (now U.S. Pat. No. 6,019,722), and show heart retractor50 in detail. The retractor permits regional and specific immobilizationof the heart while permitting essentially unabated cardiac outputwhereby all coronary arteries, including the circumflex coronary artery,to be bypassed and the heart maintained in an unnatural position and/ororientation. The retractor includes a gross support means 52 forengaging an apex portion (gross weight) of a heart to support the heartwhen the heart is lifted for surgery. Support means 52 includes acup-shaped portion 54 having a top rim 56 and an apex 58 with ribs 60defined adjacent to the apex to support the heart in the cup-shapedelement. No limitation as to specific shape is intended for element 52.Vacuum ports 62 are defined through the cup-shaped element at apex 58 tobe fluidically connected with a vacuum source for securing the heart inplace in the cup-shaped element. A vacuum source V is fluidicallyconnected to holes 62 via main support arm 64 which has one end thereoffixed to a stationary support S (see FIG. 10), such as the operatingtable, or a rib spreader, and the other end thereof attached to thecup-shaped element via fastener 66 attached to anchor 68. Amanifold-like portion 70 of the cup-shaped element distributes thevacuum to the various ports, such as ports 62 to be applied to secureretractor 50 to the heart. An alternative form of the retractor includesa separate hose to transfer vacuum to the manifold 70. Ribs 60 keepheart fat from clogging the vacuum manifold section.

The retractor further includes a fine support means for immobilizingselected portions of the heart while permitting non-immobilized portionsto move in a manner that continues heart operation. This fine supportmeans includes a plurality of rigid arms 80 each being fixed at one endthereof to anchor 68 and having a heart-attaching element 82 thereon,such as at the outer end thereof. As used herein, the term “rigid” is arelative term and means that the arms are rigid enough whereby the forceof the heart won't move them. But they can be adjustable such as beingformed of a wire-wound gooseneck or soft metal which allows each arm tobe individually shaped according to the needs of the attachmentlocation. The heart-attaching elements can be suction attachment points,such as suction cups that are fluidically connected to manifold 70.Other means of attaching the elements to the heart can be used as well.Examples of other such elements include glue, sutures, clamps, shallowpins, pincers or the like, with attachment points being located on thearm as suitable. The rigid arms secure small or fine areas of the heartin place with respect to gross support element 52 while permitting theheart to move as required to continue unabated cardiac output. Theretractor further includes a plurality of flexible support arms 84 eachfixed at one end thereof to anchor 68 and having a heart-attachingelement 86 on the outer end thereof. Elements 86 can be suction elementssimilar to the just-discussed elements 82. Flexible arms 84 can beadjusted to secure the heart in the most advantageous locations wherebythe heart can continue to operate without undue restriction.

Referring to FIG. 10, it can be seen that the retractor includes asurgery target-immobilizing element 100 for immobilizing that exactlocation of the heart on which surgery is being performed. Element 100includes a rigid arm 102 fixed at one end 104 to connecting arm 106 ofstationary main arm 64 and having a U-shaped target-defining element 108on the other end. Element 108 includes two legs 110 and 112 connected bya central section 114. As shown in FIG. 10, the target vein 116 beingincised at 118 is located between legs 110 and 112. Element 108 is rigidas is arm 102 so target area 118 will be immobile even though theremainder of the heart adjacent to this area will be moving. However,only a small section of the heart will be immobilized and thus shouldnot affect the overall operation of the heart during the operation. Thetarget-immobilizing element can be moved anywhere it is needed by simplyloosening clamp 120 and moving arm 102 as necessary.

FIGS. 11, 12, 13, 14, 15, and 16 correspond to FIGS. 7A, 8, 9, 24, 14B,and 14C of parent application Ser. No. 09/087,511 (now U.S. Pat. No.6,338,712). Parent application Ser. No. 09/087,511 (now U.S. Pat. No.6,338,712) discloses a heart manipulation system which utilizes aspecial suction cup to attach various elements thereof to the beatingheart in a manner that permits the heart and the myocardium to moveduring heart operation without unduly affecting the attachment of theelement to the heart. The suction cup applies suction to the heartsurface from a L act source of suction. Such a suction cup disclosed inparent application Ser. No. 09/087,511 (now U.S. Pat. No. 6,338,712) issuction cup 200 of FIG. 11 (of the present application), which is asuction cup that is most useful with non-flaccid tissue in which it iseasier to make the suction cup conform to the tissue than to force thetissue to conform to the suction cup. Another suction cup disclosed inparent application Ser. No. 09/087,511 (now U.S. Pat. No. 6,338,712) ismost useful with flaccid tissue which is easier to force to conform tothe shape of the suction cup.

Suction cup 200 shown in FIG. 11 includes a plurality of chambers and ameans for preventing tissue from interfering with suction being appliedthereto. Specifically, suction cup 200 is a multi-section suction cupwhich includes a first chamber 202 having a flexible rim 204 forengaging the tissue M of a heart, a second chamber 206 for fluidicallyconnecting first chamber 202 the source of suction via suction line 208.Second chamber 206 of the suction cup has a size that is different fromthe size of first chamber 202, and a shoulder 209 is formed at theconnection between first and second chambers 202 and 206. A mesh gridelement 210 is connected to the suction cup, preferably adjacent toshoulder 209, and spans first chamber 206. Flexible rim 204 is flexiblein a plurality of planes to accommodate multiplanar movement of thesurface of the beating heart without breaking contact between thesurface of the heart and flexible rim 204.

As can be understood from FIG. 11, suction cup 200 will not breaksuction with tissue T even if the tissue is drawn into the suction cupand a large area of applied suction is maintained due to the large areaA′ of first chamber 206. Thus, suction cup 200 is able to adapt tomovement of the heart and movement of the myocardium while maintaining alarge suction force on the tissue. Since chamber 202 is large, rim 204can be large and thus its flexibility can be increased.

Mesh grid element 210 functions to preserve suction pressure on thetissue even if the tissue is drawn into the suction cup. Thus, mesh gridelement 210 has a first portion that can be engaged by the tissue, and asecond portion that will remain open even when the first portion isengaged by tissue.

A heart manipulation system 300 for use in cardiac surgery is broadlyshown in FIG. 12 as comprising a frame 302 that can be located withinthe patient's thoracic cavity during beating heart surgery and whichincludes means for engaging the pericardial cavity of the patient formounting said frame on the patient to move with the patient if thepatient is moved or re-oriented during surgery.

Frame 302 includes a cross bar 303 that includes a multiplicity of teeth303T thereon. Frame 302 further includes means for engaging the patientto support the frame in position in the patient. A preferred form ofthis means includes two sternal spacers 304 which set the depth of theframe into the chest cavity and keep the frame from twisting as thelungs inflate and which are connected on cross bar 303 by a ratchet-likemechanism 305 that has teeth which engage teeth 303T when the spacersare in the desired location. The frame is expanded inside thepericardial cavity with the cross bar. A handle 305H is operated to setthe teeth of the mechanism 305 to teeth 303T. The frame can be eitherC-shaped or hoop shaped and can be secured to the patient or to anoutside stable support. Other anchor means can be used.

A source of suction is located outside the patient and is used to attachvarious elements to the patient's heart. Most often, a source of vacuumis from the operating room source which provides approximately 100 to180 mm of Hg vacuum.

As shown in FIG. 12, system 300 includes a suspension head mechanism 312movably mounted on frame 302 for lifting the heart. Mechanism 312includes a head 314 which engages the heart and which is shown in FIG.13 as being located near the apical region of the right ventricle toprevent collapse of the right ventricle during manipulation of theheart. As is also shown in FIG. 13, suspension head 314 at leastpartially overlies the right ventricle. Suspension head mechanism 312includes a flexible means 316, such as a spring, for connecting flexiblehead 314 to arm 318 and for permitting multiplanar relative movementbetween the beating heart and arm means 318 mounting suspension head 314on frame means 300. Suspension head 314 includes a suction cup such asdisclosed above in FIG. 11 connected to the source of suction and whichincludes a flexible rim engaging the myocardium of the heart and beingflexible in a plurality of planes so multiplanar movement of themyocardium during operation of the heart will be accommodated by theflexible rim whereby suction applied to the myocardium by the suctioncup will not be broken by separation of the myocardium from the suctioncup. The suction cup of head 314 includes means, such as theabove-discussed mesh grid, for preventing heart tissue from interferingwith suction being applied to the myocardium via head 314.

Arm 318 is flexible in one condition as discussed in the parentdisclosure, and is made rigid by manipulation of control and anchorelement 324. Anchor element 324 includes a base 324A which is movablymounted on cross bar 303 and has internal teeth that engage teeth 303T,and a lever system for locking the internal teeth of element 324 toteeth 303T when desired. A further lever-operated mechanism lockscorresponding elements in arm 318 whereby arm 318 is rendered rigid. Arm318 includes a flexible central line extending from head 314, throughflexible element 316 to anchor element 324 and a plurality of relativelymovable sections, such as balls 326 interposed between links 328, on thecentral line. A lever 330 is connected to the central line and when thelever is operated, the elements 326 and 328 are forced together torender the arm rigid. In this manner, the suspension head 314 can beeasily maneuvered on a flexible arm into the desired position and thenlocked into that position by rendering arm 318 rigid. Flexible means 316permits multiplanar movement of suspension head 314 even after arm 318is made rigid whereby movement of a beating heart is accommodated bysuspension head mechanism 312. When suction is applied to the heart viahead 314 the heart will be suspended and can be lifted into the desiredposition and orientation for cardiac surgery without interruptingcardiac output. The combination of the suction cup, the flexible/rigidarm, the flexible means and the location of the head on the heart effectthis result. Various forms of head 314 can be used.

With the heart supported by suspension means 312, the cardiac surgerycan be completed if desired. As will be discussed below, however,additional support can be provided. A surgery target immobilizer can beused to locally immobilize the heart while permitting the non-engagedportions of the heart to continue to operate so as to maintain cardiacoutput essentially unabated. Means 340 (shown in FIGS. 13 and 14) is ameans for locally engaging a selected section of the heart and locallyimmobilizing the heart adjacent to a surgery target so the heart issupported by the suspension head mechanism and can receive furthersupport from the surgery target immobilizing means and can thus be freeto operate during surgery while it is also locally immobilized at thesurgery target with non-engaged sections of the heart free to move in amanner whereby essentially unabated cardiac output is maintained whilethe heart is locally immobilized. Each surgery target immobilizing means340 includes a flexible section 342, such as suction cup, on a rigidelement SIR. The suction cups attached to each rigid element areconnected by suction line 208 to the source of suction and each includesa flexible rim engaging the myocardium of the heart and being flexiblein a plurality of planes so multiplanar movement of the myocardiumduring operation of the heart will be accommodated by the flexible rimof the surgery-target immobilizing means whereby suction applied to themyocardium by the suction cup of the surgery target immobilizing meanswill not be broken by separation of the myocardium, from the suction cupof the surgery target immobilizing means. Suction cups of the surgerytarget immobilizing means each include means for preventing heart tissuefrom interfering with suction being applied to the myocardium via saidsuction cup of the surgery target immobilizing means.

In some circumstances, two point support is preferred when performingcardiac surgery. Accordingly, manipulation system 300 of provides agross support means 400 movably mounted on frame 302 for engaging theheart to support the heart when the heart is oriented for surgery andwhich can be located at the base of the heart and which cradles themyocardium of the left ventricle along the arterialventricular groove(AV). Gross support means 400 is shown in FIGS. 12, 13, 15, and 16. Asbroadly shown in FIG. 12, gross support means 400 includes a head 402that is engaged with the heart and which is movably connected to frame302 by an arm mechanism 403 similar to arm 318 to be flexible andmovable with respect to the heart and with respect to frame 302 whendesired, and then rendered rigid by operation of a lever 404 of ananchor mechanism 406 that can be located on cross bar 303 or on one ofthe sternum retractors 304. Operation of the flexible arm 403 isidentical to that of arm 318 and thus will not be again discussed.

Gross support means 400 supports the mitral valve annulus to maintaincompetent mitral valve function and head 402 is placed beneath aninfolded section of myocardium. Gross support means 400 includes ahandle 408 which is attached to head 402 and which extends outside ofthe patient during surgery for adjusting the location of gross supportmeans head 402.

Head 402 is shown in FIGS. 15 and 16 as including a rigid supportsection 406 connected to a flexible section 408 having malleable rodmeans 410 received in bores 411 defined in head 402 for retaining aconfiguration that has been set for head 402 and for connecting head 402to the arm 403 for mounting gross support means 400 on frame 302. Head402 can include a plurality of sections which are movable relative toeach other and means for maintaining those sections in a selectedrelative orientation. In this manner, head 402 can be shaped to bestsupport the heart and can be adjusted to meet the needs of an individualheart. As head 314 is also adaptable to the size and shape of anindividual heart, the two-point support of system 300 can be adjustedand customized to fit the exact needs of each individual heart.

As shown in FIGS. 15 and 16, head 402 includes means for applyingsuction from the source of suction to the heart. This means includes amesh grid means 210 attached to head 402 and spanning a first chamberabove a suction applying manifold that is fluidically connected to thesource of suction by suction line 208 for preventing heart tissue frominterfering with suction applied by suspension head 402 to the heart.Frame 424 maintains mesh grid means 210 (which comprises first portion212 and second portion 214) in place on head 402, and ribs, such as rib426 and 428 can be used to maintain the desired position of mesh gridelement 210 with respect to suction holes 208.

Using the system 300, a method of performing heart surgery comprisessteps of placing frame 300 in the patient, slightly infolding the leftatrium of a heart adjacent to the base of the heart, engaging the heartunder the edge of the myocardium at the base of the heart with grosssupport means 400 then using handle 408 tilting and lifting the heart.The heart is engaged near the apex of the heart with suspension head 314to lift the heart. Such engagement prevents right ventricle collapse.This provides two point support if desired. However, the suspensionmeans alone may be sufficient in some cases to move the heart asnecessary. The method can further include a step of using surgery targetimmobilizing means 340 shown in FIG. 14 to apply suction to the heartadjacent to the selected surgical target for engaging that selectedsection of the heart and immobilizing that selected section as a surgerytarget while permitting non-engaged sections of the heart to move andpermitting essentially unabated cardiac output to be maintained whilethe heart is regionally immobilized.

Alternative forms of the frame 300 can be used, provided the frame islocated to move with the patient.

The improvement in the heart manipulation system which is the subject ofthe present invention utilizes either mechanical or adhesive means toreleasably attach an element of a heart manipulation system to theheart. These means can be used in place of or in addition to the meansdisclosed in the parent applications.

As shown in FIG. 1, a special cup 10 is used to attach various elementsof the heart manipulation system to the beating heart H in a manner thatpermits the heart and the myocardium to move during heart operationwithout unduly affecting the attachment of the element to the heart. Thecup 10 can be adapted to apply suction to the heart, but need not andcan be designed to have several degrees of freedom whereby the heart canmove without undue restriction from cup 10. Specifically, cup 10 has aflexible wall 12 and a flexible rim 14 and is attached to an arm 16 atan apex portion 18 of the cup. The flexible wall permits the cup to movein a plurality of planes so the heart can move relative to arm 16.

The means for releasably attaching cup 10 to the heart can includemechanical means. As used herein, the term “mechanical means” includessutures, staples and other such mechanical elements and fasteners asopposed to suction and chemical means.

One form of mechanical means for releasably attaching elements of theheart manipulation system to the heart includes sutures 20. Sutures 20include needles 22 which are threaded through the heart manipulationsystem element, such as cup 10, and then through the heart tissue, andthen back through the heart tissue and back through the system elementand out of the patient. Sutures 20 can also include elements, such aspledgets 24 for holding the suture in place on the heart and forspreading out the force applied by each suture to the heart tissue. Thesutures can be set in any manner known to those skilled in the art. Onceset, the sutures are tied off and then serve as a means for attachingthe system element to the heart. The sutures are cut when the element isto be released from the heart.

As shown in FIG. 1, the element, such as cup 10, can include extensions,such as extension 26, having suture-accommodating holes 28 definedtherethrough. However, the element need not include the extensions, andthe holes 28 can be defined in the element itself or the sutures can bedrawn through the element without the need of such holes 28 withoutdeparting from the scope of the present disclosure.

In one embodiment, the invention is a heart manipulation system(including the elements shown in FIG. 1) for use in cardiac surgery, thesystem comprising: a frame (e.g., a frame such as frame 302 of FIG. 12)configured to be located inside a patient during beating heart surgeryand which includes means for engaging the pericardial cavity of thepatient for mounting said frame on the patient to move with the patientif the patient is moved or re-oriented during surgery; a suspension head(e.g., cup 10) movably mounted on said frame for lifting the heart andwhich is configured to be positioned near the apical region of the rightventricle to prevent collapse of the right ventricle during manipulationof the heart and at least partially overlying the right ventricle andwhich includes a flexible means (e.g., flexible wall 12 of FIG. 1 ormeans 316 of FIG. 12) for permitting multiplanar relative movementbetween the beating heart and means mounting the suspension head on theframe means, said suspension head including a flexible rim engaging themyocardium of the heart and being flexible in a plurality of planes somultiplanar movement of the myocardium during operation of the heartwill be accommodated by the flexible rim; means for releasably attachingthe suspension head to the heart (e.g., sutures 20 of FIG. 1); a grosssupport means 70 (shown in FIG. 1) movably mounted on the frame forengaging the heart to support the heart when the heart is oriented forsurgery and which is configured to be positioned at the base of theheart to cradle the myocardium of the left ventricle along thearterialventricular groove; and means for releasably attaching the grosssupport means to the heart (means 71 shown in FIG. 1).

While sutures 20 are shown in FIGS. 1 and 2 as extending throughextensions 26 of cup 10, these sutures could be sewn through the elementitself without departing from the scope of the present invention. Infact, the sutures need not be located near the perimeter of the element,but could be placed in any suitable location on the element withoutdeparting from the scope of the present invention. The sutures can bemanipulated in any suitable manner and can take the form of any sutureknown to those skilled in the art without departing from the scope ofthe present disclosure. Those skilled in the art will understand whattype of suture works best in any given application based on their ownknowledge and the teaching of the present invention and the presentdisclosure. Accordingly, the term “suture” is intended to cover anysuture known to those skilled in the art that will work in theapplication disclosed herein.

Yet another form of mechanical means for releasably attaching an elementof the heart manipulation system to the heart is shown in FIGS. 3 and 4as including a staple 30. Staple 30 is set and formed according to knownprocedures from the unformed condition shown in FIG. 3 to the formedconfiguration shown in FIG. 4. Staples, such as those used to close skincan also be used and still be within the teaching of this invention. Anextension 32 is included on the heart manipulation system element, suchas cup 10, and has a distal end 34 with a neck 36 defined therein. A tab38 is located on the distal end and includes a groove 40 that permits aportion 41 of a staple removing tool, such as tool 42 shown in FIG. 5,to be inserted beneath the staple for removing that staple from theformed configuration shown in FIG. 4. Once the staples are removed, theelement can be released from attachment to the heart. Portion 41 ismanipulated by handle 44 via pivot 46 to unform the staple to releasethe staple from the heart.

Yet another form of mechanical means is illustrated in FIGS. 6 and 7 asa plurality of anchor wires 50 located inside the element beingreleasably attached to heart H. Each anchor wire 50 include a curled,pre-shaped end 52 which curls up inside the heart tissue once the wireis inserted into the tissue to fasten the element to the heart. Theanchor wires extend inside the element from apex 18 to and out of rim 14and the curled bias thereof is overcome by the inside surface of theelement as indicated at end 52′ shown in FIG. 6. The wire curls as itexits the element and enters the heart tissue. A plurality of wires canbe used as indicated in FIG. 7, and the wires can be used in conjunctionwith, or in place of, suction and/or other mechanical means, such as thesutures and/or staples disclosed hereinabove.

An adhesive means can also be used to releasably attach the heartmanipulation system element to the heart. As shown in FIG. 8, surgicaladhesive 60 can be placed on the element near rim 14 to releasablyattach the element to heart H. A wick 62 can be included in the elementto ensure the delivery of bonding activators or de-bonding agentsdirectly to the adhesive layer. Solvent can be applied to the adhesivevia wick 62 to release the adhesive from the heart as will occur tothose skilled in the art based on the teaching of the presentdisclosure. Any suitable surgical adhesive can be used and those skilledin the art will understand what adhesive is best based on the teachingof the present disclosure. In addition, heat or light or moisturesensitive adhesives could be used to releasably attach elements of theheart manipulation system to the heart without departing from the scopeof the present disclosure. The particular adhesive forms no part of thepresent invention and thus will not be discussed.

As is the case above, the adhesive can be used in conjunction with or inplace of the suction and/or the mechanical means for releasablyattaching the element to the heart.

It is understood that while certain forms of the present invention havebeen illustrated and described herein, it is not to be limited to thespecific forms or arrangements of parts described and shown. Forexample, tissue-gripping needles on a pad can be used to attach theelements of the heart manipulation system to the heart, suchtissue-gripping needles would be self-contained and quickly deployed.These needles would work in the manner of a skin stapler but would bemore convenient since they could deployed by a mechanism on theattachment element, Such needles can be anchored to the element beingattached to the heart, and released using tools similar to those used toremove small suture needles in other applications or have integrateddeployment or retraction means. The needles need not be formed with aforming device but can also be of a pre-formed configuration, such as ahelix, or the like and can be self-tapped into the heart. The heartattachment system is not dependent on suction alone and, as can beunderstood from the foregoing teaching, can include various other meansin addition to, or instead of, suction. Combinations of the variousmechanical and adhesive and suction means can be used as will beunderstood from the teaching of this disclosure.

What is claimed is:
 1. A manipulation system for cardiac surgerycomprising: a cup adapted to attach to the heart; and releasableattachment means for releasably attaching said cup to the heart, whereinsaid cup is configured to exert lifting force on the heart, and whereinsaid releasable attachment means further assure that said cup does notbecome unexpectedly detached from the heart said cup further beingconfigured to accommodate multiplanar movement of the beating heartwhile attached by the releasable attachment means to the beating heart.2. The manipulation system defined in claim 1 wherein said releasableattachment means includes sutures.
 3. The manipulation system defined inclaim 2, wherein said releasable attachment means includes needles. 4.The manipulation system defined in claim 1 wherein said releasableattachment means includes adhesive.
 5. The manipulation system definedin claim 1 wherein said releasable attachment means includes staples. 6.The manipulation system defined in claim 1 wherein said releasableattachment means includes mechanical elements.
 7. In a manipulationsystem for cardiac surgery which includes means for engaging a selectedsection of a beating heart to immobilize that selected section as asurgery target while permitting non-engaged sections of the heart tomove in a manner whereby essentially unabated cardiac output ismaintained while the heart is regionally immobilized, the improvementcomprising: a suspension head; a releasable attachment means forreleasably attaching the suspension head to the surface of the beatingheart, wherein the suspension head is configured to lift the beatingheart when the releasable attachment means is positioned against thesurface of the heart near the apical region of the heart and thesuspension head is attached to the surface of the heart by thereleasable attachment means, said suspension head being configured toaccommodate multiplanar movement of the beating heart while thereleasable attachment means attaches said suspension head to the surfaceof the beating heart.
 8. The improvement of claim 7, wherein thereleasable attachment means includes mechanical elements.
 9. Theimprovement of claim 8, wherein the mechanical elements include sutures.10. The improvement of claim 8, wherein the mechanical elements includestaples.
 11. The improvement of claim 7, wherein the suspension head hasa flexible portion configured to accommodate multiplanar surface motionof the beating heart.
 12. A heart manipulation system for use in cardiacsurgery comprising: a frame that is configured to be positioned inside apatient during beating heart surgery and which includes means forengaging the pericardial cavity of the patient for mounting said frameon the patient to move with the patient if the patient is moved orre-oriented during surgery; a suspension head movably mounted on saidframe for lifting the heart and which is configured to be positionednear the apical region of the right ventricle to prevent collapse of theright ventricle during manipulation of the heart and at least partiallyoverlying the right ventricle and which includes a flexible means forpermitting multiplanar relative movement between the beating heart andmeans mounting the suspension head on said frame means; releasableattachment means for releasably attaching said suspension head to theheart; a means for locally engaging a selected section of the heart andlocally immobilizing the heart adjacent to a surgery target so the heartis supported and free to operate during surgery while it is also locallyimmobilized at the surgery target with non-engaged sections of the heartfree to move in a manner whereby essentially unabated cardiac output ismaintained while the heart is locally immobilized; and a gross supportmeans movably mounted on said frame for engaging the heart to supportthe heart when the heart is oriented for surgery and which is configuredto be positioned at the base of the heart and to cradle the myocardiumof the left ventricle along the arterialventricular groove.
 13. Theheart manipulation system defined in claim 12 wherein said releasableattachment means includes sutures.
 14. The heart manipulation systemdefined in claim 13, wherein the releasable attachment means includesthe sutures, and wherein the suspension head has a rim and an extensionon the rim to which said sutures are attached.
 15. The heartmanipulation system defined in claim 13, wherein said releasableattachment means includes needles.
 16. The heart manipulation systemdefined in claim 12 wherein said releasable attachment means includesadhesive.
 17. The heart manipulation system defined in claim 12 whereinsaid releasable attachment means includes staples.
 18. The heartmanipulation system defined in claim 12 wherein said releasableattachment means includes mechanical elements.
 19. The manipulationsystem of claim 12, wherein said suspension head includes a flexible rimengaging the myocardium of the heart and being flexible in a pluralityof planes so multiplanar movement of the myocardium during operation ofthe heart will be accommodated by said flexible rim.
 20. Themanipulation system of claim 12, wherein said flexible means forpermitting relative movement includes a flexible rim for engaging themyocardium of the heart, the flexible rim being flexible in a pluralityof planes so that multiplanar movement of the myocardium duringoperation of the heart is accommodated by said flexible rim.
 21. A heartmanipulation system for use in cardiac surgery comprising: a frame whichis configured to be located inside a patient during beating heartsurgery and is configured to be mounted on the patient to move with thepatient; a suspension head mounted on said frame for lifting the beatingheart and which includes a flexible portion, said flexible portion beingflexible in a plurality of planes to accommodate multiplanar movement ofthe surface of the beating heart during beating heart surgery; means forreleasably attaching said suspension head to the heart; and means forengaging a selected section of the heart to immobilize that selectedsection as a surgery target while permitting non-engaged sections of theheart to move in a manner whereby essentially unabated cardiac output ismaintained while the heart is locally immobilized.
 22. A manipulationsystem for cardiac surgery, comprising: a suspension head; releasableattachment means for releasably attaching said suspension head to theheart, wherein the releasable attachment means is at least one of amechanical means and an adhesive means, the suspension head isconfigured to exert lifting force on the heart when attached to theheart by the releasable attachment means in a position near the apicalregion of the heart and at least partially overlying the rightventricle, and the suspension head is configured to accommodatemultiplanar movement of the beating heart while attached by thereleasable attachment means to the beating heart; and means for engaginga selected section of the heart to immobilize that selected section as asurgery target while permitting non-engaged sections of the heart tomove in a manner whereby essentially unabated cardiac output ismaintained while the heart is regionally immobilized.
 23. A manipulationsystem for use in cardiac surgery comprising: a gross support means forengaging and supporting a beating heart when the heart is located andoriented for surgery and which is configured to be located at the baseof the heart to engage the beating heart at a location that supports themitral valve annulus and which includes a flexible head which is sizedand shaped to extend along the arterialventricular groove of the heart;means for immobilizing the heart adjacent to a surgery target so theheart is supported and free to operate during surgery while it is alsolocally immobilized at the surgery target; a suspension head; andreleasable attachment means for releasably attaching said suspensionhead to the heart, wherein the suspension head is configured to exertlifting force on the heart when attached to the heart by the releasableattachment means in a position near the apex of the heart, and thesuspension head is configured to accommodate multiplanar surfacemovement of the beating heart while attached to the beating heart by thereleasable attachment means.
 24. A manipulation system for cardiacsurgery comprising: a suspension head; releasable attachment means forreleasably attaching said suspension head to the heart, wherein thereleasable attachment means is at least one of a mechanical means and anadhesive means, the suspension head is configured to exert lifting forceon the heart when attached to the heart by the releasable attachmentmeans in a position near the apical region of the heart and at leastpartially overlying the right ventricle, and the suspension head isconfigured to accommodate multiplanar movement of the beating heartwhile attached by the releasable attachment means to the beating heart;and a gross support means for engaging a beating heart and supportingthe heart when the heart is located and oriented for surgery, said grosssupport means being configured to be positioned at the base of the heartand including a head which is sized and shaped to cradle the myocardiumof the left ventricle along the arterialventricular groove.